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Toggle Summary Vertex Announces Sustained Viral Response Rate (SVR4) Data from All-Oral Study of VX-135 in Combination with Daclatasvir in Hepatitis C
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the first data from the initial cohorts of an open-label Phase 2a study of VX-135, Vertex's nucleotide analogue hepatitis C virus (HCV) polymerase inhibitor, in combination with daclatasvir, Bristol-Myers
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Toggle Summary Vertex Sells INCIVO ® Product Royalty Rights for $152 Million
-Vertex to receive $152 million cash payment from Janssen in 2013; will no longer receive royalties on INCIVO sales beginning in 2014- -Company increases 2013 year-end guidance for cash, cash equivalents and marketable securities to in excess of $1.4 billion - CAMBRIDGE, Mass.
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Toggle Summary Vertex Provides Update on Ongoing All-Oral Studies of VX-135 in Hepatitis C
-U.S. Study: FDA places partial clinical hold on ongoing Phase 2 U.S. study of VX-135, preventing evaluation of 200 mg dose following observation of elevated liver enzymes in patients receiving 400 mg of VX-135 in combination with ribavirin in Phase 2 study in Europe ; evaluation of 100 mg dose
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Toggle Summary Vertex Announces New Data that Showed High Viral Cure Rates with a Total of 12 and 24 Weeks of Telaprevir Combination Treatment Among People with Genotype 1 Hepatitis C Who Have the IL28B CC Genotype
- Interim analysis of the Phase 3b CONCISE study showed SVR12 rates of 87 percent with 12 total weeks of treatment and 97 percent with 24 total weeks of treatment among people who achieved RVR and completed 12 weeks of treatment - AMSTERDAM --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated
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Toggle Summary ALS-2200 (VX-135) Viral Kinetic Study Shows Significant Reduction in HCV RNA in People with Genotype 1 Hepatitis C Virus Infection and Cirrhosis, and in People with Genotypes 2, 3 or 4 HCV Infection
- After seven days of once-daily dosing with 200 mg of ALS-2200, genotype 1 patients with cirrhosis had a median 4.08 log 10 reduction in HCV RNA; among people with genotypes 3 or 4, there was a median 4.65 log 10 reduction in HCV RNA - - Data are consistent with previously reported ALS-2200
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Toggle Summary Vertex Announces Update to U.S. Prescribing Information for INCIVEK® (telaprevir)
- Revised label includes Boxed Warning detailing risk of serious skin reactions observed in the post-marketing setting that require treatment discontinuation - CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the INCIVEK ® (telaprevir)
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Toggle Summary INCIVEK™ (telaprevir) Now Funded in Alberta and New Brunswick for People with Hepatitis C
- Majority of provinces now fund INCIVEK -
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Toggle Summary Data from Viral Kinetic Study Showed Rapid Reduction of HCV RNA with ALS-2200 (VX-135), Vertex's Oral Nucleotide Analogue in Development for the Treatment of Hepatitis C
- 4.54 log 10 median reduction in HCV RNA after 7 days of dosing; ALS-2200 was well-tolerated with no serious adverse events and no discontinuations due to adverse events - - Vertex moving forward with multiple Phase 2 trials in early 2013 exploring all-oral combinations, including VX-135 with
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Toggle Summary Vertex Enters Agreement with GlaxoSmithKline for Phase 2 All-Oral Study of VX-135 and GSK2336805 for the Treatment of Hepatitis C
-Companies to evaluate two-drug combination of Vertex's investigational nucleotide analogue VX-135 and GSK's investigational NS5A inhibitor GSK2336805- -Phase 2 proof-of-concept study to begin in early 2013 to evaluate safety, tolerability and viral cure rates of 12-week treatment regimen-
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Toggle Summary Vertex Announces Collaboration with Janssen To Initiate Phase 2 All-Oral Study of VX-135 and Simeprevir (TMC435) for the Treatment of Hepatitis C
-Companies to evaluate two-drug combination of Vertex's investigational nucleotide analogue VX-135 and Janssen's investigational protease inhibitor simeprevir (TMC435)- -Phase 2 proof-of-concept study to begin in early 2013 to evaluate safety, tolerability and viral cure rates of 12-week treatment
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Toggle Summary Vertex Announces Presentation of New Data from Hepatitis C Development Program at AASLD Annual Meeting
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that 11 abstracts from its hepatitis C research and development program will be presented at The Liver Meeting ® , the 63rd Annual Meeting of the American Association for the Study of Liver
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Toggle Summary Vertex Announces New Data on ALS-2200 in People With Hepatitis C, Supporting Advancement into Phase 2 All-Oral Studies in 2012; Ends Development of ALS-2158
- ALS-2158: Well-tolerated in a seven-day viral kinetic study; development discontinued due to lack of efficacy - - ALS-2200: Data from additional cohort of seven-day viral kinetic study with ALS-2200 (200 mg, QD) in combination with ribavirin show median 4.18 log 10 reduction in HCV RNA with 5 of
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Toggle Summary Vertex Announces Positive Results from Viral Kinetic Study of the Nucleotide Analogue ALS-2200 in People with Hepatitis C
- 4.54 log 10 median reduction in HCV RNA observed in people with genotype 1 hepatitis C treated with a once-daily 200 mg dose of ALS-2200 for seven days; treatment was well-tolerated- - Phase 2 studies of 12-week all-oral regimens planned for this year - CAMBRIDGE, Mass.
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Toggle Summary INCIVEK™ (telaprevir) Now Funded for People With Hepatitis C in Quebec and Saskatchewan
- Vertex working with other provincial funding agencies to make INCIVEK available to more people in Canada - LAVAL, Quebec --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the province of Quebec is now funding INCIVEK ™ (telaprevir) tablets for residents
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Toggle Summary Vertex Advances INCIVEK™ (telaprevir) and Broad Portfolio of Medicines in Development With Goal of Further Expanding and Improving Treatment for People With Hepatitis C
- Subanalysis of Phase 2 data shows 12 weeks of INCIVEK combination treatment resulted in a viral cure (SVR) for 100% of people with hepatitis C who had the IL28B CC genotype; Phase 3 study enrolling - - Vertex's four direct-acting antivirals allow for the clinical exploration of multiple
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Toggle Summary Data from Phase 2 Study of an INCIVEK® Combination Regimen Showed 74% of People Co-Infected with Hepatitis C and HIV Had Undetectable Hepatitis C Virus 12 Weeks After Treatment Ended (SVR12)
- INCIVEK was well tolerated with commonly used Atripla- and Reyataz-based HIV treatment regimens, and no patients experienced HIV breakthrough - - Enrollment is ongoing in Phase 3 study evaluating 24- and 48-week treatment durations in people who are co-infected - SEATTLE --(BUSINESS WIRE)--
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Toggle Summary Vertex Announces 12-Week On-Treatment Data and SVR4 From Phase 2 Study of Interferon-Free (All-Oral) Treatment Regimen of INCIVEK®, VX-222 and Ribavirin in People with Genotype 1 Hepatitis C
- Company plans to start Phase 2b study in Q3 2012 to evaluate this interferon-free combination regimen in a total treatment duration as short as 12 weeks - - Vertex also announces the advancement of its broad portfolio of direct acting antivirals, including its two structurally-distinct nucleotide
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Toggle Summary Vertex and Alios BioPharma Begin Clinical Studies of Nucleotide Drug Candidates ALS-2200 and ALS-2158 for the Treatment of Hepatitis C
-Studies to evaluate safety and effects on viral kinetics in people with chronic genotype-1 hepatitis C- -Data expected in second quarter of 2012 could enable initiation of interferon-free, nucleotide-based combination studies in the second half of 2012- CAMBRIDGE, Mass.
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Toggle Summary Interim Data from Phase 2 Study Showed 93% of People with Hepatitis C Who Received a Total of 12 Weeks of a Combination Regimen Including INCIVEK™ (telaprevir) and VX-222 (400mg) Achieved a Viral Cure (SVR)
- Vertex announces it intends to start a Phase 3 study to evaluate a 12-week regimen in treatment naive and relapser patients with genotype 1 hepatitis C - SAN FRANCISCO --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today interim results from ZENITH, an ongoing
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Toggle Summary Positive Interim Data From a Phase 2 Study of INCIVEK™ (telaprevir) Combination Therapy in People Co-Infected with Hepatitis C and HIV Presented at The Liver Meeting®
- Data showed 74% of people had undetectable hepatitis C virus 24 weeks after starting INCIVEK combination treatment - - Vertex to initiate Phase 3 study to evaluate 24- and 48-week treatment durations in people who are co-infected - SAN FRANCISCO --(BUSINESS WIRE)-- Vertex Pharmaceuticals
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Toggle Summary Vertex Announces Recipients of Special Grants Initiative to Support People with Hepatitis C
- Hep-C Circle of Care grants will fund new and existing programs with the potential to enhance patient care - CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has awarded 16 grants totaling approximately $1.5 million to a variety of
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Toggle Summary Vertex Starts Global Phase 3b Study to Evaluate the Potential for People with Hepatitis C to Achieve a Viral Cure (SVR) with a Total Treatment Duration of 12 Weeks of INCIVEK™ Combination Therapy
— CONCISE study will evaluate twice-daily INCIVEK in combination with pegylated-interferon and ribavirin among patients new to treatment and prior relapsers who have the ‘CC' variation near the IL28B gene — CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
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Toggle Summary INCIVEK™ (telaprevir) Now Available in Canada for People with Hepatitis C
Nearly 4 out of 5 people treated for the first time cleared the virus with INCIVEK combination treatment
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Toggle Summary New England Journal of Medicine Publishes Data from Phase 3 ILLUMINATE Study of INCIVEK™ (telaprevir) in Hepatitis C
- High viral cure rate achieved with a 24-week INCIVEK combination regimen - CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the New England Journal of Medicine (NEJM) published data from a Phase 3 study of INCIVEK™ (telaprevir) tablets
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Toggle Summary Health Canada Approves INCIVEK™ (telaprevir) for People With Hepatitis C
- Nearly 4 out of 5 people treated for the first time cleared the virus with INCIVEK combination treatment - CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Health Canada has approved INCIVEK™ (telaprevir) tablets for a broad group of
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Toggle Summary Interim Data from Phase 2 Study of Combination Regimen Including VX-222 and INCIVEK™ Suggest Potential to Treat Genotype 1 Hepatitis C in as few as 12 Weeks and No More Than 24 Weeks
-First data to show potential for viral cure in many patients with a 12-week combination regimen of multiple direct-acting antivirals- CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced interim results from ZENITH, an ongoing Phase 2 study
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Toggle Summary New England Journal of Medicine Publishes Data From Two Phase 3 Studies of INCIVEK™ (telaprevir) in Hepatitis C
-INCIVEK was recently approved by the FDA and is now available for people with the most common form of chronic hepatitis C who are new to treatment and those who were treated before but not cured- CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced
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Toggle Summary FDA Approves INCIVEK™ (telaprevir) for People with Hepatitis C
-79% of people treated for the first time achieved a SVR (viral cure) with INCIVEK combination treatment- -Vertex launches a comprehensive financial assistance and patient support program- -Conference call today at 11:00 a.m. ET to provide more information on the commercialization of INCIVEK-
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Toggle Summary FDA Advisory Committee Unanimously Recommends Approval of Telaprevir for People with Hepatitis C
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the Antiviral Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) voted unanimously to recommend FDA approval of telaprevir for people with genotype 1 chronic hepatitis
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Toggle Summary Data From Phase 3 Studies Showed Substantial Improvements in SVR (Viral Cure) Rates With Telaprevir-Based Therapy Compared to Currently Available Medicines in People With Hepatitis C, Regardless of Their IL28B Genotype Status
- 90% of people with the ‘CC' variation of IL28B who were new to treatment and received a telaprevir-based regimen achieved a viral cure, 78% of them were eligible to stop all treatment at 24 weeks - - Nearly three-fold improvement in viral cure rates was observed among people with the ‘CT' and
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Toggle Summary Results From Phase 3 REALIZE Study Showed Telaprevir-Based Therapy Significantly Improved SVR (Viral Cure) Rates in People Whose Prior Treatment For Hepatitis C Was Unsuccessful
- All major subgroups achieved significantly higher viral cure rates with telaprevir-based therapy compared to pegylated-interferon and ribavirin: 86% vs. 24% in prior relapsers, 57% vs. 15% in prior partial responders and 31% vs. 5% in prior null responders - - No clinical benefit was observed in
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Toggle Summary Interim Phase 2 Data Showed Rapid Viral Response to VX-222 in Combination with Telaprevir, Pegylated-Interferon and Ribavirin Among People With Hepatitis C
BERLIN--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced interim results from an ongoing Phase 2 study (ZENITH) designed to assess the safety and tolerability of 12-week response-guided treatment regimens with its polymerase inhibitor, VX-222, and its protease
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Toggle Summary New Data on Telaprevir and VX-222 for the Treatment of Hepatitis C Accepted For Presentation at EASL Annual Meeting
  - Complete results from pivotal Phase 3 REALIZE study of telaprevir in people who had not achieved a viral cure (SVR) with currently available medicines - - First presentation of data from ongoing Phase 2 study evaluating response-guided, 12- and 24-week regimens of telaprevir and VX-222 combined
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Toggle Summary Positive Phase 2 Interim Data from First Study of Telaprevir in People Co-Infected with Hepatitis C and HIV Presented at CROI Conference
Early results from ongoing study showed that the hepatitis C virus was undetectable by week 4 in 70% of people treated with telaprevir-based combination therapy
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Toggle Summary U.S. FDA and Health Canada Grant Priority Reviews for Telaprevir for the Treatment of Hepatitis C
-Six-month review date of May 23, 2011 set by FDA- CAMBRIDGE, Mass., Jan 20, 2011 (BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration ( FDA) has accepted the New Drug Application (NDA) for telaprevir and granted the
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Toggle Summary Vertex Provides Update to Ongoing Phase 2 Study Evaluating Combinations of Telaprevir and VX-222 for the Treatment of Hepatitis C
-Two-drug treatment arm of telaprevir and VX-222 alone discontinued- -Study continues with three arms, including all-oral combination of Vertex's lead protease and polymerase inhibitors with ribavirin- -Both of the four-drug treatment arms are fully enrolled; the majority of patients in these arms
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Toggle Summary Vertex Completes New Drug Application for Telaprevir for Hepatitis C
- Submission based on results from Phase 3 studies that showed high SVR (viral cure) rates with telaprevir-based combination therapy compared to approved medicines - - Six-Month Priority Review Requested - CAMBRIDGE, Mass., Nov 23, 2010 (BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq:
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Toggle Summary Vertex Announces Plans to Enroll Additional Treatment Arm in Ongoing Phase 2 Combination Study of Telaprevir and VX-222 for the Treatment of People with Hepatitis C
-New treatment arm to evaluate all oral, triple combination regimen of telaprevir, VX-222, and ribavirin- CAMBRIDGE, Mass., Nov 10, 2010 (BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced plans to enroll an additional treatment arm as part of its ongoing Phase 2
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Toggle Summary New Data From Phase 3 Studies Showed Superior SVR (Viral Cure) Rates Achieved with Telaprevir-Based Combination Therapy in People with Hepatitis C, Regardless of Race or Stage of Liver Disease
<i>-75% of people treated in the Phase 3 ADVANCE study achieved a viral cure with telaprevir; majority of people treated for a total of 24 weeks-</i> <br /> <i>-62% of African Americans/Blacks in the ADVANCE study achieved a viral cure with telaprevir-</i> <br /> <i>-Low discontinuation rates of all drugs due to adverse events-</i> <br />
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Toggle Summary Vertex Pharmaceuticals Announces Start of a Phase 3b Study of Twice-Daily Telaprevir in People Not Treated Previously for Hepatitis C
<i>- First Phase 3 study to evaluate twice-daily (BID) dosing of a protease inhibitor for hepatitis C -</i> <br /> <i>- All patients will receive telaprevir-based combination therapy -</i> <br />
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Toggle Summary 65% of People Whose Prior Treatment for Hepatitis C Was Unsuccessful Achieved SVR (Viral Cure) with Telaprevir-Based Therapy in Phase 3 REALIZE Study
<i>-17% of people achieved SVR with pegylated-interferon and ribavirin alone in the control arm-</i> <br /> <i>-Safety and tolerability results were consistent with prior Phase 3 studies-</i> <br /> <i>-Completion of rolling New Drug Application submission on track for the fourth quarter 2010-</i> <br />
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Toggle Summary Phase 3 ILLUMINATE Study Supports 24-Week Telaprevir-Based Therapy Within a Response-Guided Regimen for People with Hepatitis C Who Had Not Received Prior Treatment
<i>-Viral cure rates of 92% and 88% with 24 and 48-week regimens, respectively, in people who met certain response criteria-</i> <br /> <i>-Safety and tolerability results were similar to those seen in the Phase 3 ADVANCE study</i>- <br />
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Toggle Summary 75% of Treatment-Naïve Patients with Chronic Hepatitis C Achieve SVR (Viral Cure) with Telaprevir-Based Treatment in Phase 3 Trial
<i><b>-Majority of patients treated with telaprevir received a 24-week regimen-</b></i> <br /> <i><b>-6.9% and 7.7% treatment discontinuation rates due to adverse events in 12- and 8-week telaprevir-based treatment arms -- lower than previous telaprevir trials-</b></i> <br /> <i><b>-First Phase 3 trial results for a direct acting antiviral therapy in hepatitis C-</b></i> <br />
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Toggle Summary Hepatitis C Virus Polymerase Inhibitor VX-222 Reduced Viral Levels Over Three Days in Phase 1b Trial
<i>-VX-222 was well-tolerated across all four dose groups through three days of dosing, with all adverse events being mild to moderate in severity-</i> <br /> <i>-Greater than 3 log</i><sub><i>10 </i></sub><i>reduction in HCV RNA observed across all four VX-222 dose groups-</i> <br /> <i>-Results support previously announced Phase 2 proof-of-concept clinical trial evaluating VX-222 in combination with Vertex's lead HCV protease inhibitor telaprevir-</i> <br />
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Toggle Summary 59 Percent of Patients Overall Achieved SVR with Telaprevir-Based Regimens in Study 107 After Not Achieving SVR with at Least One Prior Course of Treatment for Hepatitis C Virus Infection
<i>-56% of prior treatment null responder patients achieved SVR with a 48-week telaprevir-based regimen-</i> <br /> <i>-97% of prior treatment relapsers and 55% of prior treatment partial responders achieved SVR with 24-week or 48-week telaprevir-based regimens-</i> <br />
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Toggle Summary New England Journal of Medicine Publishes PROVE 3 Trial Showing Telaprevir-Based Regimens Significantly Increased Sustained Viral Response (SVR) Rates in Patients Who Did Not Achieve SVR with Prior HCV Therapy
<i><b>-51% and 53% SVR rates when telaprevir was dosed in combination with pegylated-interferon and ribavirin in treatment-failure patients, compared to 14% SVR rate with pegylated-interferon and ribavirin alone-</b></i> <br /> <i><b>-Telaprevir Phase 3 SVR data expected in second quarter 2010 for treatment-naïve patients and third quarter 2010 for treatment-failure patients-</b></i> <br /> <i><b>-New Drug Application submission planned for second half of 2010 in treatment-naïve and treatment-failure HCV patients-</b></i> <br />
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Toggle Summary Vertex Pharmaceuticals Announces Acceptance of Telaprevir and VX-222 Abstracts for Presentation at EASL Annual Meeting
CAMBRIDGE, Mass., Mar 16, 2010 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that multiple abstracts related to the hepatitis C virus (HCV) protease inhibitor telaprevir and the HCV polymerase inhibitor VX-222 were accepted for presentation at the 45 th
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Toggle Summary Vertex Broadens its Commitment to Improving HCV Care with Clinical Trial to Evaluate Combination Regimens Based on Oral Antiviral Therapies
<i>-Trial will evaluate safety and SVR rates with multiple 12-week response-guided regimens of telaprevir/VX-222-based combination therapy, including two-drug regimens of telaprevir and VX-222-</i> <br /> <i>-Interim clinical data expected in the second half of 2010-</i> <br /> <i>-Multiple clinical trial sites in the U.S. to enroll patients-</i> <br />
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Toggle Summary Telaprevir Presentations at the 59th AASLD Meeting to Feature SVR Data in Treatment-Naïve and Treatment-Failure Genotype 1 HCV Patients, and Clinical Data Exploring Twice-Daily Dosing Regimens
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX - News) today announced that key data on sustained viral response (SVR) rates in both treatment-naïve and treatment-failure genotype 1 hepatitis C (HCV) patients who received telaprevir-based treatment regimens
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Toggle Summary Vertex Pharmaceuticals Announces Correction to Abstract Data Published in October 2008 Supplement to Hepatology
CAMBRIDGE, Mass., Sep 24, 2008 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today provided a correction to AASLD abstract 1854 published in the October 2008 supplement of the journal Hepatology. The title of the abstract is "Phase 2 Study of Telaprevir Administered q8h or
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